검색어: accelerated stability testing (영어 - 그리스어)

stability testing
έλεγχος σταθερότητας

stability testing:
Δοκιμή σταθερότητας:

in-use stability testing
έλεγχος σταθερότητας κατά τη χρήση

stability testing of existing active
Οµάδα εργασίας της cvmp για τη φαρµακοεπαγρύπνηση

in-use stability testing of veterinary medicinal products
in- use stability testing of veterinary medicinal products

stability testing of biotechnological/biological veterinary medicinal products adopted june 2000
biotechnological/ biological veterinary medicinal products

stability testing of existing active substances and related finished products adopted november 2000
substances and related finished products

cen -en 13640:2002 stability testing of in vitro diagnostic reagents -— --
cen -en 13640:2002 Δοκιμή σταθερότητας για in vitro διαγνωστικά αντιδραστήρια -— --

annex to note for guidance on stability testing of existing active substances and related finished products.
annex to note for guidance on stability testing of existing active substances and related finished products.

stability testing: stability testing of existing active substances and related finished products – revision
quality of water for pharmaceutical use quality of water for pharmaceutical use – revision quality of modified release dosage forms for veterinary use

in-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
in- use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)

document title in-use stability testing of veterinary medicinal products use of near infrared spectroscopy by the pharmaceutical industry modified release oral and transdermal dosage forms revision:
Τίτλος εγγράφου in- use stability testing of veterinary medicinal products use of near infrared spectroscopy by the pharmaceutical industry modified release oral and transdermal dosage forms revision:

the applicant stated that no protocol was established before the in vitro comparison but that in house documents with pre-specified criteria were used and that test product batches were subjected to release and stability testing according to protocols from the quality control department.
Ο αιτών ανέφερε ότι δεν είχε θεσπίσει πρωτόκολλο πριν από τη διεξαγωγή της in vitro σύγκρισης, αλλά ότι είχε χρησιμοποιήσει εσωτερικά έγγραφα με προκαθορισμένα κριτήρια, καθώς και ότι οι παρτίδες του προϊόντος δοκιμής υποβλήθηκαν σε έλεγχο διάθεσης και σταθερότητας με βάση τα πρωτόκολλα του τμήματος ποιοτικού ελέγχου.

anotherequally appealing and important issue for the future of the office will be the decisionstaken based on the results of the studies which have been under way for calculatingcosts for dus (distinctness, uniformity and stability) testing, which new varieties ofplants applying for protection must undergo.
Στο εγγύς μέλλον, το ΚΓΦΠ θα κληθεί να αντιμετωπίσει νέες προοπτικές και προκλή­σεις, συμπεριλαμβανομένης της ελκυστικής προοπτικής της διεύρυνσης της Ευρωπαϊκής Ενωσης.

7/ 19 the results of the in-use stability testing of the product after 15 months storage at 25°c/ 60% rh and in-use of 12 months after opening showed acceptable stability.
Τα αποτελέσµατα της δοκιµής σταθερότητας του εν χρήσει προϊόντος µετά από αποθήκευση επί 15 µήνες σε θερµοκρασία 25°c και σχετική υγρασία 60% και της δοκιµής του εν χρήσει προϊόντος 12 µήνες µετά από το άνοιγµα της συσκευασίας κατέδειξαν ότι η σταθερότητα του προϊόντος είναι αποδεκτή.

final guidelines • choice of control group in clinical trials (cpmp/ ich/ 364/ 96), ich e10 • clinical investigation of medicinal products in children (cpmp/ ich/ 2711/ 99), ich e11 • safety pharmacology studies for human pharmaceuticals (cpmp/ ich/ 539/ 00), ich s7a • stability testing guidelines: stability testing of new active substances and medicinal products (cpmp/ ich/ 2736/ 99 rev. of cpmp/ ich/ 380/ 95), ich q1ar • non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (cpmp/ ich/ 286/ 95, modification), ich m3 modification • reproductive toxicology: toxicity to male fertility (cpmp/ ich/ 136/ 95 modification), ich s5b modification • data elements for transmission of individual case safety reports (cpmp/ ich/ 287/ 95 modification), ich e2b • recommendations on electronic transmission of individual case safety reports message specification (cpmp/ ich/ 285/ 95), ich m2 • good manufacturing practice guide for active pharmaceutical ingredients (cpmp/ ich/ 4106/ 00), ich q7a • common technical document (ctd), (cpmp/ ich/ 2887/ 99), ich m4
choice of control group in clinical trials (cpmp/ ich/ 364/ 96), ich e10 clinical investigation of medicinal products in children (cpmp/ ich/ 2711/ 99), ich e11 safety pharmacology studies for human pharmaceuticals (cpmp/ ich/ 539/ 00), ich s7a stability testing guidelines: stability testing of new active substances and medicinal products (cpmp/ ich/ 2736/ 99 rev. of cpmp/ ich/ 380/ 95), ich q1ar non- clinical safety studies for the conduct of human clinical trials for pharmaceuticals (cpmp/ ich/ 286/ 95, modification), ich m3 modification reproductive toxicology: toxicity to male fertility (cpmp/ ich/ 136/ 95 modification), ich s5b modification data elements for transmission of individual case safety reports (cpmp/ ich/ 287/ 95 modification), ich e2b recommendations on electronic transmission of individual case safety reports message specification (cpmp/ ich/ 285/ 95), ich m2 good manufacturing practice guide for active pharmaceutical ingredients (cpmp/ ich/ 4106/ 00), ich q7a common technical document (ctd), (cpmp/ ich/ 2887/ 99), ich m4